Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world.

Position Summary:

The Associate Process Engineer supports daily operations in a cGMP environment by offering technical support on projects. The environment is dynamic, with multiple molecules in production simultaneously. This will accelerate an aspiring Process or Chemical Engineer's career with early exposure to Upstream and Downstream Biologic Drug Substance Manufacturing in a CDMO. The position offers exposure to many unit operations, including Mammalian Cell Culture expansion and production in Single Use Bioreactors, as well as Monoclonal Antibody (mAb) purification through Chromatography and Filtration processes.

The opportunity will support the Process Engineers and Process Validation Engineers with Tech Transfer (TT) and Process Performance Qualification (PPQ) activities to prepare for Right-First-Time (RFT) readiness of upcoming clinical and commercial batches for our customers.

Location/Division Specific Information

This role is a full-time permanent position, based onsite at our Kent Street, Brisbane office.

Key Responsibilities:

Execution and Operations Support

• Support ongoing batch execution by completing assigned standard work and reporting, under mentorship from Support and Process Engineers.
• Monitor Critical-to-Quality (CTQ) process steps during manufacturing.
• Collaborate with Operations teams on problem solving and deviation handling
• Build and maintain execution guidance for technical and operations staff with support from Project Engineers.
• Support delivery of Key Performance Indicators for the Brisbane site and Large Molecule network.

Documentation and Protocol Drafting

• Author GMP-Critical documentation including Standard Operating Procedures (SOPs), Validation Protocols/Reports, Master Batch Records, Process Flow Diagrams, Risk Assessments and Bills of Materials (BOM).
• Maintain GMP documentation and written guidance, ensuring accuracy and version control.

Data Handling and Process Supervision

• Manage the Process Data Management System (Discoverant) by ensuring accurate data recording, detailed analysis, and scheduled reporting.
• Compile data and statistical analysis for Continued Process Verification (CPV), process monitoring and problem solving.

Technology Transfer and Project Assistance

• Assist with technology transfer and implementation of New Product Introductions (NPIs) for our customers.
• Support facility fit process modelling as directed.
• Support CAPEX projects through introduction of new technologies to the facility.

Continuous Improvement and Compliance

• Participate in Practical Process Improvement (PPI) activities by identifying improvements in ways of working and supporting implementation.
   

Qualifications & Experience

• Tertiary degree in Chemical or Process Engineering (preferably Master-level majoring in Pharmaceutical Processing, Bioprocess, Biomedical)
• Up to 2 years of industry experience or internship in Bioprocessing, Biopharma, pharmaceuticals at lab to manufacturing scale advantageous.
• Experience in technology transfer and scaling up is advantageous.

Skills & Attributes

• Proficient with Microsoft Office suite
• Demonstrated learning agility to new technology and systems
• Experience with coding software advantageous (i.e python, matlab, VBA)
• Ability to apply Engineering first principles to problem solving.
• Excellent interpersonal skills and professionalism in the workplace
• Continuous Improvement methodology (Lean, Six Sigma) and familiarity with tools and techniques desirable.
• Desire for career progression to leadership and client-facing roles.

Other Important Information

• Possesses right to work in Australia

Other Job Requirements

• Follow OHS policies and procedures to maintain a safe and healthy workplace environment
• Your position may require you to participate in on call work. If you are on call you are required to be available for immediate return to work outside of your normal and regular work pattern. Should this be a requirement of your position, you will be remunerated per the Company’s policy.

Benefits

Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.

• Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
• Flexibility: Balance your work and personal life with flexible arrangements.
• Extra Leave: Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.
• Charitable Giving & Volunteering: Make an impact with paid volunteer time to support non-profit organizations that matter to you.
• Learning & Development: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.

Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 125,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.